Effects of the GOLO Weight Management Program With and Without Release Supplement on Weight and Metabolic Parameters in Subjects With Obesity

Phase 3

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Release Supplement

• Registration Number: NCT03842501
• Lead Sponsor: Golo

Brief Summary

This randomized, double-blind placebo-controlled study was intended to measure the effects of the GWMP with Release supplement versus GWMP with placebo supplement in a representative group of obese subjects with or without diabetes at one outpatient medical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2018-12-24
• Study Completion: 2018-12-24
• Status Verified: 2019-02
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-14
• Last Update Submitted: 2019-02-14
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Age ≥ 18 years and ≤ 80 years
2. Body mass index (BMI) ≥ 30 and ≤ 60 kg/m2
3. Have the ability to engage in at least 15 minutes of moderate physical activity such as brisk walking
4. Willing to comply with study procedures described herein

Exclusion Criteria

1. Current diagnosis of type 1 diabetes

2. Subjects with a history of hypoglycemia

3. A history of an eating disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

4. Known allergy to any of the components in the Release supplement

5. A history of prior surgery for weight loss

6. Currently taking injectable medications to control diabetes, including insulin and GLP-1 agonists

7. Currently pregnant or breastfeeding or have had a baby within the last six weeks

8. Planning to become pregnant in the next three months. Women of child bearing potential must be willing and able to use adequate and reliable contraception throughout the study (e.g. abstinence or barrier with additional spermicidal foam or jelly, or the use of intrauterine device or hormonal contraception).

9. Uncontrolled hypertension at screening defined as Systolic blood pressure greater than 180 mmHG or Diastolic blood pressure greater than 110 mmHG

10. Current clinical diagnosis or signs and symptoms of unstable (in the opinion of the principle investigator) heart, kidney or liver disease, cancer, or chronic neurological disease.

11. Current participation in any other weight loss or weight management program

12. Currently taking weight loss medications, or medications or supplements known to be associated with significant weight loss or weight gain

13. Has any condition that, in the opinion of the investigator, would make participation in this study not in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments. Examples include: history of diabetic ketoacidosis; active chronic liver disease or cirrhosis; chronic autoimmune disease; inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, subjects predisposed to intestinal obstruction; chronic intestinal diseases associated with marked disorders of digestion or absorption

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Release supplement	Release Supplement	-

Primary Outcome Measures

Name	Time	Method
Change in weight from baseline	13 weeks

Secondary Outcome Measures

Name	Time	Method
Change in waist circumference from baseline	13 weeks
Change in fasting glucose from baseline	13 weeks
Change in Hemoglobin A1C from baseline	13 weeks

Trial Locations

Locations (1)

Buynak Clinical Research; 🇺🇸 Valparaiso, Indiana, United States